DIETARY SUPPLEMENTS: A NEW SHERIFF IN TOWN
In March 2009, President Barack Obama appointed long-time public health expert Dr. Margaret A. Hamburg, who will succeed Dr. Andrew von Eschenvach, who has led the highly criticized agency since 2005. In a statement by Steve Mister, President of the Counsel for Responsible Nutrition (“CRN”), “the more than 150 million Americans who use dietary supplements each year need to have confidence not only in the companies that make dietary supplements, but also in the Agency that enforces the regulations and laws by which these products are made.” Although Dr. Hamburg admittedly during one of the Senate Confirmation Hearings stated she had not been “deeply involved with dietary supplement issues in the past,” she has the confidence of President Obama to fulfill his promise to overhaul the $2 billion agency. Let’s hope so.
According to the January 2009 report from the Government Accountability Office (“GAO”), “sales of dietary supplements alone reached approximately 23.7 billion in 2007 and have been estimated at 75,000 dietary supplement products available to consumers.”
Although in the GAO report, “the FDA dedicates relativity few resources to dietary supplement oversight activities, including conducting inspections and developing guidance for industry on key safety issues related to aspects of DSHEA (Dietary Supplement Health Education Act). In this report, the GAO acknowledges “DSHEA authorized FDA to establish CGMP (current good manufacturing practice) specific to dietary supplements in 1994, however, the Agency did not publish a proposed rule until 2003 and did not finalize the rule until 2007.” “Because these current good manufacturing practices are phased in over time, they will not fully be in effect until 2010 – 16 years after the FDA was authorized to establish them.” Similarly, FDA officials have admitted “the difficulty of banning of a dietary supplement because FDA must establish adulteration under the significant or an unreasonable risk standard. For example, it took the FDA almost 10 years after issuing its first advisory about Ephedra to gather sufficient data to meet the statutory version of proof for banning Ephedra from the market.”
The FDA has collaborated with the National Institute of Health Office of Dietary Supplement to provide information to the public with regard to carefully using dietary supplements, however, because of the lack of data and only recent mandatory reporting for serious and adverse events, the dietary supplement industry from a consumer standpoint will remain a minefield for consumers and a goldmine for manufacturers.